[ad_1]
National pharmaceutical companies reach 10 companies in clinical trials related to ‘therapeutics’
Global pharmaceutical company, leader in Pfizer and Modena, accelerates development of ‘vaccines’
The momentum of the new coronavirus infection (Corona 19) is increasing day by day. The cumulative number of confirmed cases worldwide exceeded 60 million and the cumulative number of deaths also reached 1.5 million. In Korea, the number of new confirmed cases surpassed 500 in 8 months after the March pandemic.
For this reason, domestic and foreign pharmaceutical and biological companies are vigorously pursuing the development of COVID-19 treatments and vaccines. In the case of Korea, more than 10 pharmaceutical and biological companies are focusing on developing ‘therapeutic drugs’, and global pharmaceutical companies abroad are focusing on developing ‘vaccines’ based on various platforms.
According to data released by the Ministry of Food and Drug Safety, there are a total of 22 Corona 19-related clinical trials currently underway in Korea. Of these, 11 national pharmaceutical and biological companies are conducting 14 clinical trials related to therapeutic agents.
Celltrion antibody treatment ‘CT-P59 (ingredient name: Regdanbimab)’ is receiving the most attention. Celltrion is currently in three clinical trials related to CT-P59.
First, safety and tolerability were ensured, as no unusual abnormal cases were observed as a result of the study in phase 1 clinical trials conducted in patients with mild corona19.
Kim Jin-yong, an infectious medicine specialist at Incheon Medical Center, who participated in the clinical trial, said: “In fact, it was confirmed that symptoms were alleviated when CT-P59 was administered to mild patients in the early stages of Corona 19 I confirmed that it was abbreviated. “
There is also a phase 2/3 clinical trial approved by the Ministry of Food and Drug Safety in September. Celltrion has conducted phase 2 clinical trials worldwide in major national medical institutions, as well as in countries such as the United States, Spain and Romania, and has completed medication for 327 patients.
The most recent phase 3 clinical trial approved in October focuses on “prevention.” CT-P59 clinical phase 3 aims to confirm the effect of preventing infection and killing the virus in the early stages in close contact and in confirmed asymptomatic patients who have come into contact with Corona 19 infected patients.
Celltrion is also considering the Corona 19 trend, global clinical outcomes in the future, and is applying for a conditional permit through prior consultation with the Ministry of Food and Drug Safety.
Shinpoong Pharmaceutical, which has been classified as a ‘crown thematic stock’ and has increased in stock, is conducting phase 2 clinical trials in Korea and South Africa of ‘Piramax (ingredient name: pyronaridine phosphate, altesunate)’, an anti-malaria treatment.
Pyramax drew attention when the results of the in vitro experiment announced by the company were released. The main components of Piramax, pyranaridine and altesunate, each showed the effect of inhibiting the Corona 19 virus.
Furthermore, when the two components were used in combination, the virus titer inhibition rate was greater than 99% after 24 hours and persistence improved up to 48 hours. The results of the company’s ongoing phase 2 clinical trials are expected to be released as soon as possible within this year, and Shinpoong Pharmaceutical plans to apply for emergency use approval from the Ministry of Food and Drug Safety based on the clinical trial results.
Additionally, Bukwang Pharm (Revovir), NG Chem Life Science (EC-18), Daewoong Pharm (DWJ1248, DWRX2003), Dong Wha Pharm (DW2008S), Green Cross (GC5131), Genexine (GX-I7), NewGen Therapeutics (NewGen Napamostat Tablet), Chong Kun Dang (CKD-314), Crystal Genomics (CG-CAM20) and other companies are conducting clinical trials for the treatment of COVID-19 in Korea.
Global pharmaceutical companies were playing a quick battle in the development of the Corona 19 vaccine based on various vaccine platforms.
First of all, the most striking places in terms of speed were Pfizer and Modena. Currently, both companies have demonstrated more than 90% preventive effect through phase 3 clinical trials, and Pfizer has submitted an emergency application (USA) to the US Food and Drug Administration (FDA). Modena also plans to submit an EUA to the FDA based on the final results in the near future.
The Janssen and AstraZeneca clinical trials were stopped due to safety concerns, but all were resumed. However, for AstraZeneca, the results of a recently published interim analysis are controversial.
According to data published by the company, the candidate vaccine ‘AZD1222’ showed an average immunity of 70% against Corona 19. This figure represents an average of 90% of the prophylaxis effect of the participants who received half the vaccine first, followed of a full dose one month later, and 62% of participants received the full dose of both doses. That is the result.
Experts note that AstraZeneca’s “calculation method” is highly unscientific. It is difficult to understand the summary of the results of two clinical trials with completely different dosing regimens.
Furthermore, the reliability of the data is shaking as the dose difference is known to have been caused by the ‘error’ of the researchers who conducted the clinical trial.
Meni Pangalos, AstraZeneca’s director of research and development, told foreign media: “It was planned to administer a dose to all participants in the clinical trial, but there was a miscalculation. The prevention effect was greater. It was an unexpected serendipity. “
Additionally, NovaVax, a biotech company in the United States, is conducting phase 3 clinical trials for up to 10,000 people in the United Kingdom, and Kansino, a Chinese pharmaceutical company, is conducting phase 3 clinical trials in Pakistan and Russia in September.
Furthermore, it is known that the Chinese state pharmaceutical company Sinoparm has officially requested the release of the vaccine from the health authorities (National Drug Administration).
Ryu Jing-jeon, Sinofarm’s party secretary and chairman, said in an interview with China’s Xinhua news agency that “there are about 1 million people who have been vaccinated against the Corona 19 vaccine from Sinoparm.”
Copyright © Farm News Unauthorized reproduction and redistribution prohibited
